This trial is recruiting individuals with spinal cord injuries to evaluate the effect of a small functional electrical stimulation (FES) device on trunk stability. The surgically implanted 8-channel neuroprosthesis device applies small currents through wire electrodes connected to the nerves of trunk and hip muscles; this causes those muscles to contract and strengthen. Participants will have the device implanted in the abdomen, with connecting wires placed in the trunk and hips. After a few weeks of recovery, participants will receive training and exercises on how to use the device. Assessments of FES on sitting, posture, stability, breathing, rolling over in bed, and pushing a wheelchair will occur over 36 months.
Traumatic
Non-traumatic
Type
Details
The participant will receive surgery to implant the stimulator in his abdomen and electrodes in his back and hip muscles. After the surgery, the participant will be monitored in the hospital for 2-5 days. For 2-6 weeks after the surgery, the participant will return home and be encouraged to rest and do minimal activity so that he may heal. The participant will then receive exercise and training to use the stimulation device. The investigators have not yet provided information on the number or duration of therapy sessions.
Main benefits
Standing/walking/mobility
Additional benefits
General health
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn moreWings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more